CMC Regulatory Services
In the field of CMC, our expert staff apply highly specialized skills to perform the tasks described below. They deliver regulatory affairs services of impeccable quality in support of customers inside and outside Japan across a broad range of activities.
Our CMC services range from support for drug substance filings and drug product approvals, to advice on GMP and consistency check.
Services Outline
Accreditation of Foreign Manufacturers
- New Accreditation
- Renewal of Accreditation
- Addition of Accreditation Category
API
- MF Registrations
- MF ICC (In-Country Caretaker)
- M2 Preparation
- MF Review Response Management
- GMP Compliance Reviews
Regulatory CMC consultation
- Support of Marketing Authorization Application
- Preparation of Application Form
- Support preparation of attached documents
Performance Profile
Sales Component by Services (2019 – 2021)
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Sales Component by Countries (2019 – 2021)
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